HepRiACT: Hepatitis C Rimantadine and Antiviral Combination Therapy

Sponsor

The Leeds Teaching Hospitals NHS Trust (Other)

Overall Status

Completed

CT.gov ID

NCT01413490

Collaborator

Cancer Research UK (Other)

Enrollment

Location

Duration (Months)

0.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Hepatitis C virus is one of the leading causes of liver failure and liver cancer worldwide. Current treatment of hepatitis C infection is only successful in about half of those who are eligible. The current treatment aims to boost the host immune system but does not directly act on the virus. Many drugs are in various stages of development that target the virus directly - their specific mode of action is confirmed by showing the virus is forced to adapt in the presence of the drug. As with many viruses, treating with only one specific drug would quickly lead to the virus adapting and becoming resistant. We therefore need to find new combinations of directly acting drugs. Rimantadine has already been shown in the laboratory to target hepatitis C directly. We have designed this study to see if it happens in real life as well. If so, we could use rimantadine to help fight hepatitis c more effectively.

Condition or Disease	Intervention/Treatment	Phase
Hepatitis C	Drug: rimantadine

Study Design

Study Type:

Observational

Actual Enrollment :

10 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

A Clinical Study to Evaluate the Biological Effects of Administering Rimantadine in Patients With Hepatitis C Virus (HCV) Infection Alongside Standard Combination Therapy With Pegylated Interferon and Ribavirin

Study Start Date :

May 1, 2012

Actual Primary Completion Date :

Mar 1, 2015

Actual Study Completion Date :

Mar 1, 2015

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Have a diagnosis of HCV infection, genotype 1 or genotype 3
Be eligible for standard combination therapy with pegylated IFN and ribavirin
Be at least 18 but no more than 65 years of age
Have signed an informed consent indicating that the patient is aware of the infectious nature of their disease and have been informed of the procedures of the protocol, the experimental nature of the therapy, alternatives, potential benefits, side effects, risks, and discomforts
Be willing and able to comply with scheduled visits, the treatment plan, and laboratory tests
Have no contraindications to receiving rimantadine therapy
Have blood results within defined acceptable haematological and biochemical parameters (haemoglobin >10 g/dl, platelet count >150 x 109/L, bilirubin <25 umol/L, albumin >35 g/L, creatinine <150 umol/L

Exclusion Criteria:

Have dementia or altered mental status that would prohibit informed consent
Have previously received treatment for HCV infection (i.e. are currently treatment naïve)
Have any condition which would deem the patient ineligible for combination therapy with pegylated IFN or ribavirin. This includes pregnancy, significant cardiac, renal or autoimmune disease, severe depression or psychosis, and previous organ transplantation
Cirrhosis or liver failure as evidenced by clinical (cutaneous stigmata of chronic liver disease, ascites, encephalopathy), ultrasonic (cirrhotic appearance of liver, ascites) or biochemical (platelet count >150 x 109/L, bilirubin <25 umol/L, albumin

35 g/L) evidence, routinely collated in all patients diagnosed with HCV

Any condition which would preclude the use of rimantadine. This comprises significant renal impairment (creatinine >150), pregnancy, epilepsy or history of unexplained seizures
Have any other severe, acute, or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration or may interfere with the interpretation of study results and, in the judgment of the Chief Investigators, would make the patient inappropriate for this study. This includes the presence of end stage liver disease (cirrhosis), and HIV infection